[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GOG Foundation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,81,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100644769","phase-2-tisotumab-vedotin-in-squamous-cell-carcinoma-of-the-vulva-100644769",false,"NCT07672782","Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva","Phase II Study Tisotumab Vedotin in Metastatic or Recurrent Squamous Cell Carcinoma of the Vulva","Inclusion Criteria:\n\n* Age ≥18 years, or considered an adult by local regulations, at time of consent.\n* Must sign an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedures.\n* Has recurrent or metastatic vulva cancer with squamous cell histology, and:\n\n  1. Has not received more than 2 prior systemic therapy regimens for recurrent and\u002For metastatic vulva cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as separate systemic therapy regimen.\n  2. Is not a candidate for curative therapy, including but not limited to radiotherapy or exenterative surgery.\n* Measurable disease according to RECIST v1.1 as assessed by the investigator, defined as:\n\n  1. A minimum of one non-nodal lesion ≥10 mm in the longest diameter from a nonirradiated area. If target lesion(s) are located within previously irradiated area only, the participant can be enrolled only if there has been demonstrated progression in the \"in field\" lesion and upon approval of the sponsor's medical monitor.\n\n     OR\n  2. Lymph node lesion ≥15 mm in the shortest diameter from a non-irradiated area.\n* Must demonstrate acceptable screening laboratory values:\n\n  1. Calculated eGFR (MDRD formula): ≥50 mL\u002Fmin\u002F1.73m\\^2\n  2. Alanine aminotransferase (ALT): ≤3× upper limit of normal (ULN) (if liver tumor\u002Fmetastases are present, then ≤5×ULN is allowed)\n  3. Aspartate aminotransferase (AST): ≤3×ULN (if liver tumor\u002Fmetastases are present, then ≤5×ULN is allowed)\n  4. Bilirubin: ≤1.5×ULN (except in participants diagnosed with Gilbert's syndrome, direct bilirubin ≤2×ULN)\n  5. Hemoglobin: ≥5.6 mmol\u002FL (9.0 g\u002FdL)\n  6. Absolute Neutrophil Count (ANC): ≥1500\u002FμL (1.5x10\\^9\u002FL)\n  7. Platelet count: ≥100×10\\^9\u002FL\n  8. For participants NOT on anti-coagulation therapy:\n\n     1. Activated partial thromboplastin time (aPTT): ≤1.5×ULN\n     2. International normalized ratio (INR): ≤1.2\n  9. For participants on anti-coagulation therapy:\n\n     1. aPTT: ≤1.5×ULN\n     2. INR: ≤2.5\n* Has ECOG performance status of 0 or 1 within 28 days prior to registration.\n* Has a negative serum pregnancy test for participants of reproductive potential. Participants that are postmenopausal, permanently sterilized or previously subjected to bilateral oophorectomy, bilateral salpingectomy and\u002For hysterectomy can be considered as not having reproductive potential.\n* Participants of reproductive potential must agree to use adequate contraception during and for 6 months after the last study treatment administration. Adequate contraception is defined as highly effective methods of contraception. Two highly effective methods of contraception must be used in countries where this is required.\n* Must agree not to breastfeed or donate ova, starting at the time of informed consent and continuing through 6 months after receiving the last dose of study drug administration.\n* If required by local health authorities, has negative serology for hepatitis B surface antigen (HBsAg)\u002FHBV DNA, or hepatitis C antibody (HCVAb) or RNA. Active hepatitis C is defined by a known positive HCVAb result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.\n* Must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.\n\nExclusion Criteria:\n\n* Has primary melanoma, adenocarcinoma, sarcomatoid, or other histologies not mentioned in inclusion criterion 3\n* Has clinically significant bleeding issues or risks:\n\n  1. Known past or current coagulation defects leading to an increased risk of bleeding\n  2. Diffuse alveolar hemorrhage from vasculitis\n  3. Known bleeding diathesis\n  4. Ongoing major bleeding (ie, participant requires a transfusion of \\>2 platelet concentrates within 14 days of the first dose of study treatment)\n  5. Trauma with increased risk of life-threatening bleeding\n  6. History of severe head trauma or intracranial surgery within 8 weeks of study entry\n* Has cardiovascular issues or risks:\n\n  1. Clinically significant cardiac disease, including unstable angina or acute myocardial infarction, 6 months prior to screening\n  2. Any medical history of congestive heart failure (grade III or IV as classified by the New York Heart Association)\n  3. Any medical history of decreased cardiac ejection fraction of \\\u003C45%\n  4. A marked baseline prolongation of QT\u002FQTc interval (eg, repeated demonstration of a QTc interval \\>450 msec)\n  5. A complete left bundle branch block (defined as a QRS interval ≥120 msec in left bundle branch block form) or an incomplete left bundle branch block\n* Central nervous system (CNS): any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack \\>28 days prior to screening is allowed).\n* Ophthalmological: Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (eg, Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), ocular Stevens-Johnson syndrome or toxic epidermal necrolysis, mucus pemphigoid, and participants with penetrating ocular transplants are ineligible. Cataracts alone is not an exclusion criterion.\n* Other cancer: known past or current malignancy other than inclusion diagnosis. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%) such as non-invasive basal cell carcinoma, non-invasive superficial bladder cancer, and ductal carcinoma in situ.\n* Brain metastases are allowed if the following criteria are met: definitive therapy (eg, surgery or stereotactic brain radiotherapy) has been completed \\>8 weeks before the first dose of study treatment; no evidence of clinical or radiologic progression of the brain metastases; participant has completed perioperative corticosteroid therapy or steroid taper. NOTE: Chronic steroid therapy is acceptable provided that the dose is stable for 28 days prior to study enrollment.\n* Surgery\u002Fprocedures: major surgery within 4 weeks (28 days) or minor surgery within 7 days prior to the first study treatment administration. Participants must have recovered adequately from the toxicity or complications from the intervention prior to starting study treatment. Participants who have planned major surgery during the treatment period must be excluded from the study.\n* Peripheral neuropathy ≥grade 2.\n* Prior anti-cancer therapy:\n\n  1. Any prior treatment with MMAE-derived drugs (e.g. Brentuximab vedotin, Polatuzumab vedotin, Tisotumab vedotin, Disitamab vedotin).\n  2. Radiotherapy for palliative intent within 21 days prior to the first administration of study treatment. Participants must have recovered from all clinically significant radiation-related toxicities. At least 42 days must have elapsed from the last administration of chemo-radiotherapy to first study treatment.\n  3. Small molecules, chemotherapy, immunotherapy, or monoclonal antibodies within 28 days prior to the first administration of study treatment.\n  4. Currently participating in or has participated in a study of an investigational agent or device and received active treatment within 28 days prior to the first dose of study treatment.\n* Other:\n\n  1. Ongoing significant, uncontrolled medical condition.\n  2. Clinically significant active viral, bacterial, or fungal infection requiring IV or oral treatment with antimicrobial therapy ending \\\u003C7 days prior to first study treatment administration.\n  3. Clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage.\n  4. Participants with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration or nutrition at the time of the first dose of study treatment.\n* Has known seropositivity of human immunodeficiency virus (HIV); known medical history of hepatitis B or C infection. Note: No testing for HIV, hepatitis B, or hepatitis C is required, unless mandated by local health authorities. Exceptions include latent or controlled HIV infection.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of tisotumab vedotin.\n* Is pregnant or intends to conceive children within 6 months of ending study treatment.\n* Is breast feeding and cannot discontinue breast feeding for the duration of the study and ≥6 months after the last study treatment administration.\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n* Known allergies, hypersensitivity, or intolerance to study treatment or its excipients (refer to the Investigator's Brochure for further information on tisotumab vedotin).\n* Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.","FEMALE","18 Years",{"count":19,"type":20},28,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is an open-label, single arm, phase 2 study designed to evaluate the efficacy of tisotumab vedotin in participants with recurrent or metastatic squamous cell carcinoma of the vulva by estimating the objective response rate.\n\nPatients will receive tisotumab vedotin every 3 weeks (21 days plus or minus 3 days). Treatment will continue until either unacceptable toxicity, progression of disease, or investigator\u002Fpatient request for withdrawal.",[26,27,28],"Vulvar Carcinoma","Recurrent or Metastatic Vulvar Cancer","Squamous Cell Carcinoma Vulva",[30,31,32,33,34,35],"Metastatic","Recurrent","Squamous Cell Carcinoma","Vulva","Advanced","Vulvar Cancer","NOT_YET_RECRUITING","2026-06-22",{"date":39,"type":40},"2026-06-29","ACTUAL",{"date":42,"type":20},"2026-11",{"date":44,"type":20},"2029-12",{"name":46,"class":47},"GOG Foundation","NETWORK",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":69,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100489919","phase-3-heated-intraperitoneal-chemotherapy-followed-by-niraparib-for-ovarian-primary-peritoneal-and-fallopian-tube-cancer-100489919","NCT05659381","Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer","GOG-3068: A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin Versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery Followed by Niraparib Maintenance in Patients With Homologous Recombinant Deficient (HRD +) Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Heated Ovarian Treatment Trial)","HOTT","Inclusion Criteria:\n\n1. Patients must have a pathologic diagnosis of high grade serous or endometroid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, FIGO stage III or IV documented on CT scan\u002FMRI, must be recommended and agree to undergo platinum-based neoadjuvant chemotherapy with or without physician choice bevacizumab (3-4 cycles allowed, with bevacizumab held for at least 28 days preoperatively) and are considered candidates for (and planned to have) interval cytoreductive surgery (iCRS) followed by chemotherapy and niraparib maintenance as determined by the enrolling investigator. Patients may continue bevacizumab after a minimum of 28 days post iCRS and during niraparib maintenance per local standard.\n2. Patients with stage IV disease must have complete response of extra-abdominal disease on preoperative imaging (e.g. pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, or other extra-abdominal metastases) or be deemed resectable with iCRS.\n3. Patients must have HRD\u002FLOH positive tumors. Patients with germline or somatic BRCA or other similar mutations (RAD51C, RAD51D, BRIP1, BARD) are not required to have HRD\u002FLOH testing. Patients without BRCA or germline mutations must have HRD\u002FLOH testing using Myriad myChoice®\u002FFoundation Medicine\u002FCaris Life Sciences platforms. HRD test results must be available prior to registration to meet entry criteria.\n4. Patients must have R0 (no gross\u002Fvisible residual disease) or R1 (gross\u002Fvisible residual disease ≤ 1.0 cm in the longest diameter) following iCRS and prior to randomization.\n5. Patient must have adequate bone marrow and organ function:\n\n   Bone marrow function:\n\n   Hemoglobin ≥ 8.5 g\u002FdL. Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm3. Platelets ≥ 100,000\u002Fmm3.\n\n   Renal function:\n\n   Creatinine ≤ 1.3mg\u002Fdl OR Calculated creatinine clearance (≥ 30 mL\u002Fmin\u002F1.73 m2) per National Kidney Foundation guidelines and NHANES III\n\n   Hepatic function:\n\n   Bilirubin ≤ 1.5 times ULN. ALT ≤ 3 times the ULN. AST ≤ 3 times the ULN.\n\n   Neurologic function:\n\n   Peripheral neuropathy ≤ CTC AE grade 2.\n6. Patients must have an ECOG performance status of 0 or 1.\n7. Patient must be age \\> 18.\n8. Patients must have a life expectancy \\> 3 months.\n9. Patients of childbearing potential must have a negative serum pregnancy test within 28 days prior to iCRS and must be practicing an effective form of contraception (with failure rate \\\u003C1% per year) during the study period and for 6 months following the last dose of niraparib. Patients of childbearing potential must consent to pregnancy testing prior to receiving niraparib and monthly thereafter for the duration of the study.\n\n   Patients are considered postmenopausal and not of child-bearing potential if they are free from menses for \\>1 year or surgically sterilized.\n10. Patients must have normal blood pressure (BP) or adequately treated and controlled hypertension based on local standard of care (systolic BP ≤ 140 mmHg and diastolic ≤ 90 mmHg) prior to starting niraparib.\n11. Patients receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to randomization.\n12. Patients must agree to not donate blood during the study or for 90 days after the last dose of study treatment.\n13. Patients with known human immunodeficiency virus (HIV) are allowed if they meet all the following criteria:\n\n    1. Cluster of differentiation 4 ≥350\u002FµL and viral load \\\u003C400 copies\u002FmL\n    2. No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months prior to enrollment\n    3. No history of HIV associated malignancy for the past 5 years\n    4. Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV started \\>4 weeks prior to study enrollment\n14. Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information.\n\nExclusion Criteria\n\n1. Patients with low-grade serous, clear cell, mucinous, non-epithelial ovarian cancers and borderline tumors.\n2. Patients who have received prior treatment for ovarian cancer other than the first 3-4 cycles of platinum based neoadjuvant chemotherapy. Prior neoadjuvant treatment with bevacizumab is allowed; bevacizumab must be held for 28 days prior to surgery.\n3. Patients whose tumors are HRD\u002FLOH negative.\n4. Patients not eligible for iCRS based on evidence of progression of disease during neoadjuvant chemotherapy (documented on CT scan\u002FMRI required within 35 days of iCRS).\n5. Patients not eligible for iCRS based on medical co-morbidities as per the enrolling investigator.\n6. Patients with stage IV disease without complete response of extra-abdominal disease on preoperative findings (e.g., pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, mesemchymal liver metastases or other extra-abdominal metastases) who are not deemed resectable with iCRS.\n7. Patients with a history of Myelodysplastic Syndrome or Acute Myeloid Leukemia.\n8. Patients who are pregnant or lactating.\n9. Patients with a severe infection requiring IV antibiotics within 2 weeks of planned randomization.\n10. Patients with other uncontrolled, intercurrent medical conditions.\n11. Patient with metastatic disease to the central nervous system.\n12. Patient with uncontrolled insulin dependent diabetes or pre-existing renal condition.\n13. Patients with pre-existing hearing loss related to prior platinum-based chemotherapy.\n14. Patients with Prior Reversible Encephalopathy Syndrome (PRES).\n15. Patients with current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment). Severe hepatic impairment patients should be excluded.\n16. Patients with any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and\u002For bowels that is not related to ovarian cancer.\n17. Patients with clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, uncontrolled cardiac arrhythmia or unstable angina \\\u003C6 months to randomization, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident within 6 months).\n18. Patients with an increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to study randomization and\u002For history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).\n19. Patients with known active hepatitis B (eg, hepatitis B surface antigen reactive) are excluded unless their HBV is stably controlled on nucleos(t)ide analogs (eg entecavir or tenofovir) which will be continued for the duration of the study.\n20. Patient has had investigational therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to study randomization.\n21. Patient has received a live vaccine within 30 days of study randomization. COVID-19 vaccines that do not contain live viruses are allowed at any time during the study.\n22. Patient has a diagnosis, detection, or treatment of another type of invasive cancer ≤ 2 years prior to initiating protocol therapy (except for basal or squamous cell carcinoma of the skin, cervical cancer in situ, and ductal cancer in situ (DCIS) that has been definitively treated).\n23. Patients must not have had radiotherapy encompassing \\> 20% of the bone marrow within 2 weeks of randomization; or any radiation therapy within 1 week prior to randomization.",{"count":58,"type":20},220,[60],"PHASE3","Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +\u002F- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.\n\nFollowing completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease \\>1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm will receive a single dose of cisplatin (100mg\u002Fm2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receive postoperative standard chemotherapy after recovery from surgery.\n\nBoth groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per standard institutional guidelines +\u002F- bevacizumab for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing +\u002F- bevacizumab until progression or 36 months (if no evidence of disease).",[63,64,65,66,67,68],"Stage III Ovarian Cancer","Stage IV Ovarian Cancer","Stage III Primary Peritoneal Cancer","Stage IV Primary Peritoneal Cancer","Stage III Fallopian Tube Cancer","Stage IV Fallopian Tube Cancer",[70],"HIPEC","RECRUITING","2026-04-15",{"date":74,"type":40},"2026-04-16",{"date":76,"type":40},"2024-03-08",{"date":78,"type":20},"2034-08-01",{"name":46,"class":47},59,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100489195","phase-2-letrozole-in-uterine-leiomyosarcoma-100489195","NCT05649956","Letrozole in Uterine Leiomyosarcoma","A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma","Inclusion Criteria:\n\n1. Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information.\n2. Patient must have histologically confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus (FIGO 2009 Stage I). Submission of pathology report documenting uterine leiomyosarcoma histology is required in the IRT Source Document Portal following randomization.\n3. Patient tumors must express ER positivity by immunohistochemistry (ER expression greater than 10% by immunohistochemistry). ER status test results must be provided at enrollment. Sites are required to report results of ER status testing in the IRT Source Document Portal.\n4. Patient must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from enrollment.\n5. All patients must have NO measurable disease as defined by RECIST 1.1 within 6 weeks of enrollment. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be greater than or equal to 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray. Lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI.\n6. Patients must have an ECOG performance status of 0, 1, or 2.\n7. Patients must have adequate organ and marrow function as defined below:\n\n   NOTE: Institutional\u002Flaboratory upper limit of normal = ULN Institutional\u002Flaboratory lower limit of normal = LLN\n\n   Bone marrow function:\n   * Absolute neutrophil count (ANC) greater than or equal to 1500 cells\u002Fmcl\n   * Platelet count greater than or equal to 100,000 cells\u002Fmcl\n   * Hemoglobin greater than or equal to 9.0 g\u002FdL (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the Investigator. Initial treatment must not begin earlier than the day after erythrocyte transfusion).\n\n   Renal function:\n\n   • Serum creatinine less than or equal to 1.5 x ULN\n\n   Hepatic function:\n   * AST (aspartate aminotransferase) and ALT (alanine aminotransferase) less than or equal to 3.0 x ULN\n   * Serum albumin greater than or equal to 2.5 g\u002FdL\n8. Patient must be at least 18 years of age.\n9. Patient must be able to swallow oral medication.\n\nExclusion Criteria:\n\nExclusion Criteria 1. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors are permitted).\n\n2\\. Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.\n\n3\\. Patients with concomitant invasive malignancy or a history of prior malignancy except non-melanoma skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.\n\n4\\. Patients who have a history of taking any aromatase inhibitor within the past 5 years.\n\n5\\. Patients with active or uncontrolled systemic infection. 6. Patients with history of uncontrolled cardiac disease, i.e., uncontrolled hypertension (defined as systolic greater than 150 mm Hg or diastolic greater than 90 mm HR despite antihypertensive medications), unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure (NYHA Class II or greater), clinically significant cardiac arrhythmias, and cardiomyopathy with an ejection fraction under 40%.\n\n7\\. Patients currently receiving chemotherapy or radiation therapy. 8. Patients with severe hepatic impairment and\u002For cirrhosis. 9. Patients with duodenal stent or other GI disorder\u002Fdefect that would interfere with absorption of oral medication.\n\n10\\. Patients deemed otherwise clinically unfit for clinical trial per investigators discretion.\n\n11\\. Patients with known hypersensitivity to any of the excipients of letrozole. 12. Patients who are pregnant or breast-feeding. 13. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days of prior to enrollment.\n\n14\\. Patients currently using systemic estrogens, including herbals and supplements with estrogenic properties. The use of vaginal estrogen is permitted if symptoms are refractory to moisturizers and lubricants.",{"count":89,"type":20},40,[23],"This is a clinical trial to test letrozole in patients with uterine leiomyosarcoma. The main question is will treatment with letrozole extend progression-free survival in patients. Patients will receive 2\u002F5 mg of letrozole daily.",[93],"Uterine Leiomyosarcoma","2026-03-26",{"date":96,"type":40},"2026-03-31",{"date":98,"type":40},"2024-07-17",{"date":100,"type":20},"2029-07-30",{"name":46,"class":47},25,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100426328","a-trial-of-robotic-versus-open-hysterectomy-surgery-in-cervix-cancer-100426328","NCT04831580","A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer","A Randomized Controlled Trial of Robotic Versus Open Surgery for Early Stage Cervical Cancer (ROCC)","ROCC","Inclusion Criteria:\n\n1. Patient must have histologically confirmed adenocarcinoma (usual\u002Fclassic\u002FNOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)\n2. Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging. Patients with tumor size less than or equal to 4 cm confirmed on MRI prior to randomization are eligible.\n3. Patient must have uterine size \\\u003C12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.\n4. Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard and agree to be randomized to undergo open or robotic radical (or simple) hysterectomy.\n\n   NOTE: Simple hysterectomy will be allowed in patients who meet the following criteria:\n   1. pelvic MRI must demonstrate a maximal tumor size of 2 cm or less AND\n   2. less than 50% stromal invasion on MRI if tumor present or less than 10 mm of stromal invasion if an excisional (cold knife or LEEP) has been performed.\n\n   Submission of source documents in the GOG Partners Source Document Portal will be required prior to randomization for review and confirmation of simple hysterectomy being met (see Section 6.0 for instructions).\n5. Patient must be age 18 years or older.\n6. Patient must have ECOG performance status 0-1.\n7. Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women.\n8. Patient must have signed an approved informed consent and authorization permitting the release of personal health information.\n\nExclusion Criteria:\n\n1. Patients with any tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, endometrioid, clear cell, serous, signet ring, minimal deviation)\n2. Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).\n3. Patient with inability to receive an MRI.\n4. Patients with a tumor size greater than 4cm or on MRI confirmed prior to randomization are excluded. Patients with definite evidence of vaginal\u002Fparametrial involvement on MRI are excluded; if MRI findings are not definitive, then clinical examination must also not reveal parametrial or vaginal extension).\n5. Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).\n6. Patients with a history of prior pelvic or abdominal radiotherapy.\n7. Patients with a prior malignancy \\\u003C 5 years from enrollment with the exception of non-melanoma skin cancer.\n8. Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.\n9. Patient compliance and geographic proximity that do not allow adequate follow-up.\n10. Patients with poorly controlled HIV with CD4 counts \\\u003C500.",{"count":112,"type":20},840,[114],"NA","This is a randomized controlled trial to compare survival for patients who undergoe robotic assisted laparoscopy versus open hysterectomy and lymph node assessment for the treatment of early stage cervical cancer.",[117],"Cervical Cancer","2024-12-16",{"date":120,"type":40},"2024-12-19",{"date":122,"type":40},"2022-03-22",{"date":124,"type":20},"2029-08",{"name":46,"class":47},136,""]